K243768
- 510(k) number
- K243768
- Device name
- iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System
- Applicant
- Restor3D, Inc. NC · US
- Product code
- MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constra
- Decision date
- 2025-03-27
- Date received
- 2024-12-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K243768.pdf
Official FDA record: K243768
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.